The Microcurrent device (Model: HBR2-1) is a hand-held, non-sterile, reusable device designed to achieve the cosmetic effect. The device consist of main unit and wireless charging station with undetachable USB cable. The device is supplied by internal rechargeable lithium battery. It can be recharged by external charger through the charging station. The device design with Micro current output stimulation function. The MCU-controlled microcurrent circuit generates a low-frequency microcurrent which will applied in the facial skin to do facial stimulation. In the microcurrent stimulation mode, there is ten levels of output intensity which would be adjusted by the button in the device. The device is only intended for home use.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary regarding the acceptance criteria and study proving device performance:

This document is a 510(k) summary for a Microcurrent device (Model: HBR2-1), seeking clearance for "microcurrent electrical to stimulate facial tissues for aesthetic purposes."

It's important to note that this document addresses substantial equivalence to predicate devices, not a direct clinical efficacy study establishing independent acceptance criteria for the device's aesthetic claims. The FDA clears devices based on demonstrating they are as safe and effective as legally marketed predicate devices, not necessarily on proving new efficacy.

Based on the provided text, a conventional clinical study with predefined acceptance criteria for device performance (e.g., specific metrics for aesthetic improvement) and a direct comparison to a control group or a human-in-the-loop scenario was not conducted or reported in this 510(k) summary. Instead, the clearance relies on demonstrating compliance with safety standards and technical equivalence to existing cleared devices.

Therefore, many of the requested categories for a typical clinical study will be marked as "Not Applicable" or "Not Provided" as they are not part of this type of submission.

Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (as per 510(k))	Reported Device Performance (as per 510(k))
1. Safety Standards Compliance	Compliance with relevant medical electrical safety, EMC, and biocompatibility standards.	- IEC 60601-1: 2012: Complies - IEC 60601-1-2: 2014: Complies - IEC 60601-1-11: 2015: Complies - IEC 60601-2-10: 2016: Complies - ISO 10993-5: 2009: Complies - ISO 10993-10: 2010: Complies - Electrical Safety: Comply with IEC 60601-1 and IEC 60601-2-10; IEC60601-2-57 IEC60601-1-11 - EMC: Comply with IEC 60601-1-2 - Biocompatibility: All user-contacting materials comply with ISO10993-5 and ISO10993-10.
2. Usability	The lay user can self-select as appropriate, apply treatment safely and correctly, and understand labeling/manual.	Usability testing was conducted and demonstrated these requirements were met.
3. Software	Software verification and validation conducted as per FDA guidance for "moderate" level of concern.	Software V&V testing was conducted, and documentation was provided. The software was determined to be of "moderate" level of concern.
4. Substantial Equivalence to Predicate Devices	Demonstrate that technological characteristics, features, specifications, materials, mode of operation, and intended use are substantially equivalent and do not raise new safety or effectiveness issues.	- Intended Use/Indications for Use: The subject device's indication ("stimulate facial tissues for aesthetic purposes") aligns with the predicates. - Electrical Parameters: While not identical, the output voltage, current, frequency, and pulse width are within ranges considered comparable or acceptable within the context of microcurrent stimulation devices and do not raise new safety/effectiveness concerns. For instance, the subject device's max current density (0.0325 mA/cm² @500Ω) is lower than both predicates (1.591mA/cm2@500Ω for K173093 and 0.044/0.42 mA/cm²@500Ω for K162106), which is generally favorable for safety. - Other Characteristics: Similarities in channels, stimulated muscles (face), auto features (overload, no-load, shut-off), user control, and material (ABS) are noted, establishing equivalence. - Differences Addressed: Key differences (e.g., prescription status of one predicate, output intensity levels) are accounted for, with the usability study addressing the OTC status.

Breakdown of Specific Study Information:

1. A table of acceptance criteria and the reported device performance: See table above.
2. Sample size used for the test set and the data provenance:
- Clinical Testing/Effectiveness: Not explicitly done or reported for proving efficacy of the aesthetic claim. The "test set" for safety and usability would be the subjects in those respective studies. The document does not specify sample sizes for these.
- Data Provenance: Not specified, but generally, for such an FDA submission, the data is generated by or for the manufacturer. No country of origin is specified for any users or test subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For demonstrating substantial equivalence and safety: The "ground truth" is established by compliance with recognized engineering and biocompatibility standards (e.g., IEC, ISO). The experts involved would be testing engineers, biocompatibility specialists, and regulatory experts within the manufacturing and consulting companies, whose specific numbers and qualifications are not detailed here. No clinical experts (e.g., dermatologists assessing aesthetic outcomes) are mentioned as establishing ground truth for efficacy, as no explicit efficacy study defined with clinical endpoints was performed for this 510(k).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned for clinical outcome adjudication, as no clinical efficacy study focusing on aesthetic outcomes was submitted. Adjudication in the context of standard testing (e.g., electrical safety) refers to whether the device passes or fails the specified test, which is a direct measurement against a standard, not a subjective interpretation.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a microcurrent stimulator for aesthetic purposes, not an AI-assisted diagnostic tool involving human readers or interpretation of cases. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm. The device operates standalone as a microcurrent stimulator without continuous human intervention during its operation, but its use is entirely human-initiated and directed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For safety and essential performance: Compliance with international safety standards (e.g., IEC 60601 series, ISO 10993 series) serves as the "ground truth." This involves direct measurement by testing laboratories.
- For usability: "Ground truth" is established by demonstrating that lay users can understand and safely operate the device based on the instructions for use.
- For substantial equivalence: The "ground truth" is established by comparing the technical specifications and intended use to those of legally marketed predicate devices, and confirming that any differences do not raise new safety or effectiveness concerns. No clinical outcomes data (e.g., quantifiable aesthetic improvement) from a dedicated study of the subject device defines the ground truth for efficacy.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or AI-based device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set is relevant to this device's clearance.

Summary

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November 5, 2021

Shenzhen DJ Medical Equipment Co., Ltd. % Jet Li Regulation Manager Guangzhou KEDA Biology Technology Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, Guangdong China

Re: K211055

Trade/Device Name: Microcurrent device (Model: HBR2-1) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: October 1, 2021 Received: October 7, 2021

Dear Jet Li:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211055

Device Name Microcurrent device (Model:HBR2-1)

Indications for Use (Describe)

The device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

510k number: K211055

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

Submitter's Information 1.

Manufacturer Name: Shenzhen DJ Medical Equipment Co., Ltd.
Address: Room 801, Building A, FirstFlag Science & Technology Park, No. 26 Baili Road, Nanwan Street., Longgang District, Shenzhen, Guangdong, China
Tel.: +86-755-8557 3525
Fax: +86-0871-67263826
Contact Person: Feiyang Huang
E-mail: info@dimiot.com

Application Correspondent

Guangzhou KEDA Biological Tech Co., Ltd.
Address: 6F, No.1 TianTairoad, Science City, LuoGang District, GuangZhou City, China ●
Contact Person: Mr. Jet Li ●
Title: Regulation Manager ●
Tel: +86-18588874857 ●
Email: med-il@foxmail.com ●

2. Subject DeviceInformation

Type of 510(k) submission: Traditional Common Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Trade Name: Microcurrent device (Model: HBR2-1) Classification Name: Stimulator, Nerve, Transcutaneous Review Panel: Neurology, Physical Medicine Product Code: NFO Regulation Number: 882.5890 Regulation Class: 2

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3. Predicate Device Information

Sponsor	TAMA ResearchCorporation	Li-Tek ElectronicsTechnologies
Device Name	TAMA BEMS Device	Micro-current WrinkleRemoving Facial Servicemodel EP-400
510(k) Number	K173093	K162106
Product Code	NFO	NFO
Regulation Number	882.5890	882.5890
Regulation Class	2	2

4. Device Description

The device design with Micro current output stimulation function. The MCU-controlled microcurrent circuit generates a low-frequency microcurrent which will applied in the facial skin to do facial stimulation. In the microcurrent stimulation mode, there is ten levels of output intensity which would be adjusted by the button in the device.

The device is only intended for home use.

5. Intended Use / Indications for Use

The device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

6. Performance Summary

The device conforms to the following standards:

IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essentialperformance

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IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromaqnetic Compatibility - Requirements and Tests.
IEC 60601-1-11:2015 Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment
IEC 60601-2-10: 2016, Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Test for in vitro cytotoxicity.
ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Test for irritation and skin sensitization.

Software Verification and Validation Testing

Software verification and validation testing were conducted and its documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to beof "moderate" level of concern.

Usability Testing

Usability testing was conducted to demonstrate that the device and its labeling can meet the following requirements:

the lay user can self-select themselves as being appropriate users of this device by the external box labeling,
the lay user can apply the treatment safely and correctly according to the instructions for use, and
the lay user can understand all indications, contraindications, warnings and precautions, and be able to identify whether they are within any contraindicated group; and be able to understand the user manual.

Clinical Testing

Clinical data were not required in this submission to support a finding of substantial equivalence.

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7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, mode of operation, and intended use of the Microcurrent device (Model: HBR2-1) is substantially equivalent to the predicate devices quoted above.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

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Elements ofComparison	Subject Device(K211055)	Primary Predicate Device(K173093)	Reference device(K162106)
Device Name andModel	Microcurrent deviceModel: HBR2-1	TAMA BEMS Device	Micro-current WrinkleRemoving Facial Service,model EP-400
Intended Use &Indications forUse	The device usesmicrocurrent electrical tostimulate facial tissues foraesthetic purposes.	The TAMA BEMS Device usesmicrocurrent electrical tostimulate facial tissues foraesthetic purposes.	The device is intended forfacial stimulation byelectrode heads forcosmetic use. The deviceis also intended for thetreatment of periorbitalwrinkles with red LightEmitting Diode (LED)head. It is for over-the-counter use.
Prescription Status	Over-the-Counter Use (OTC)Note: Usability study providedto demonstrate OTC use	Prescription Use (Rx) Only	Over-the-Counter Use(OTC)
Number ofoutputs mode	1	4	1
Number ofchannels	1	1	1
Output IntensityLevel	10	--	--
Stimulatedmuscles	Face	Face	For micro currentstimulation: Face;For Red light: periorbital
Maximum outputvoltage	0.54V@500Ω2.24V @ 2kΩ10.8V @ 10kΩ	±0.400 @500Ω±1.600 @2 k Ω±8.00 @10k Ω	1.23V @ 500Ω3.64V @ 2kΩ10.9V @ 10kΩ
Maximum OutputCurrent	1.08mA @ 500Ω1.12mA@2kΩ1.08mA@10kΩ	±0.800 @500 Ω±0.800 @2 k Ω±0.800 @10k Ω	2.46mA @ 500Ω1.82mA @ 2kΩ1.09mA @ 10kΩ
Frequency range(Hz)	8.34Hz	Frequency (Hz) [or Rate (pps)]0.045 - 2560	59.3Hz
Pulse width	60ms	Pulse Duration (msec) 52.6 - 2400	4ms
Contraction andRelaxation time	Adjustable, due to different modes.	Adjustable, due to different modes.	Adjustable, due to different modes.
Net Charge, (μC)@ 500 Ω	0μC @500Ω	0μC @500Ω	9.04μC@ 500Ω
Maximum CurrentDensity (mA/cm²@ 500Ω)	0.0325 mA/cm² @500Ω	1.591mA/cm2@500Ω	Bigger electrode head:0.044 mA/cm²@ 500ΩSmaller electrode head:0.42 mA/cm²@ 500Ω
Maximum pow erDensity	106uW/cm² @500Ω	318uW/cm2 @500Ω	Bigger electrode head0.014 mW/ cm²@ 500ΩSmaller electrode head0.139 mW/ cm²@ 500Ω
Timer Range	10 minutes	0-30 minutes	10 minutes
Additional Features
Power	Adaptor Output: DC 5V,0.3A	Internal 4.3Vrechargeable LithiumPolymer battery	1200mAh lithium battery
indication display	pow er on, pow er off,operation mode.	On/Off Display Status,Low Battery,Voltage/Current Level	On/Off Status, LowBattery, Voltage/CurrentLevel
Dimension	About 180 mm*40mm	3x5x0.7(in.)	--;
Weight	80g	9.5 ounces	--;
Housing Materials	ABS	Anodized aluminum 6061	ABS plastic
Microprocessorcontrol	Yes	Yes	Yes
AutomaticOverload trip	Yes	Yes	Yes
Automatic no-loadtrip	Yes	Yes	Yes
Automatic shut-off	Yes	Yes	Yes
User overridecontrol	Yes	Yes	Yes
Environment foroperating	Temperature: +18° C ~+40° CRelative humidity: 35 % ~75 %	--;	Temperature: 5 ~ 40° C
Environment forstorage	Temperature: -10° C ~ +55°CRelative humidity: 20 % ~80 %	--;	Temperature: -25 ~70° CHumidity: 10 ~90% RH
Biocompatibility	All user directly contactingmaterials are compliancewith ISO10993-5 andISO10993-10 requirements.	All user directly contactingmaterials are compliance withISO10993-5 and ISO10993-10requirements.	All user directly contactingmaterials are compliancewith ISO10993-5,ISO10993-10 and IEC62471:2006 requirements.
Electrical Safety	Comply with IEC 60601-1and IEC 60601-2-10;IEC60601-2-57IEC60601-1-11	Comply with IEC 60601-1 andIEC 60601-2-10	Comply with IEC 60601-1and IEC 60601-2-10
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2

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Final Conclusion:

The subject device "Microcurrent device (Model: HBR2-1)" is Substantial Equivalence to the predicate device.

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).